Glycosylation differences of an anti-VEGF monoclonal antibody (PRO-169) and its extensive comparison with Bevacizumab.

PRO-169 is an anti-VEGF monoclonal antibody developed by Laboratorios Sophia that shares its sequence with Bevacizumab (BVZ); though, PRO-169 is intended for intravitreal administration. In this study, analytical characterization showed that PRO-169 had glycosylation differences in comparison to BVZ reference product (RP); since it had more content of G1F, G2F, sialic acid and high mannose. Further investigation was performed to evaluate if differences between both products would affect the efficacy and safety profile of PRO-169.

Novel therapies for proliferative retinopathies.

Proliferative retinopathies, such as neovascular age-related macular degeneration and proliferative diabetic retinopathy, are a special health issue due to their contribution to irreversible blindness. Although the promoting conditions and physiopathology of proliferative retinopathies are different, these feature a highly detrimental angiogenesis driven by the overproduction of vascular endothelial growth factor (VEGF). This article describes the mechanism of action of ocular antiangiogenic therapies currently found in clinical development.

Evaluation of the Rheological Properties, Preclinical Safety, and Clinical Effectiveness of a New Dispersive Ophthalmic Viscoelastic Device for Cataract Surgery.

Purpose: To evaluate the rheological properties of the ophthalmic viscoelastic device (OVD) PRO-149, its preclinical safety, and its effectiveness when used during cataract surgery in patients with age-related cataract.

Material And Methods: Control (HEC) and test (PRO-149) OVDs were compared through rheological measures, by two preclinical safety studies in rabbits, and under normal-use conditions during cataract removal and lens implantation in a parallel randomized clinical trial.

Results: Rheological properties were determined.

Pharmacokinetics and Safety of an Intravitreal Humanized Anti-VEGF-A Monoclonal Antibody (PRO-169), a Biosimilar Candidate to Bevacizumab.

Background: PRO-169 is a biosimilar candidate to bevacizumab (BEV), a monoclonal antibody (mAb) that inhibits vascular endothelial growth factor-A (VEGF-A) developed for intravitreal use. The current study demonstrates the intraocular pharmacokinetics (PK) of PRO-169 and its safety using New Zealand white (NZW) rabbits.

Methods: Intraocular concentration was evaluated in thirty-six rabbits at 1h, 1, 2, 5, 14 and 30 days after a single bilateral injection of PRO-169 or BEV (1.

Physicochemical characterization of a DMPC-based nanoemulsion for dry eye and compatibility test with soft contact lenses in vitro.

Introduction: The use of contact lenses (CL) is often associated with hallmark symptoms of dry eye disease (DED) such as red eye and dryness. Even though lipid-based artificial tears are already marketed for DED, there is little evidence that supports their use while wearing soft CL.

Methods: An oil in water (O/W) nanoemulsion was formulated with a highly-stable oily phase composed of castor oil and 1,2-dimyristoyl-sn-glycero-3-phosphocholine (DMPC).